E0400 - Treatment Patterns of an Adalimumab Biosimilar (ABP 501) Among Patients With Inflammatory Bowel Disease: An Observational Study Using German Pharmacy Claims Database

Tuesday, October 25, 2022

3:00 PM – 5:00 PM ET

Location: Crown Ballroom

Presenting Author(s)

Ran Jin, MD, PhD

Amgen Inc.
Thousand Oaks, CA

Ran Jin, MD, PhD¹, Silvia Kruppert, MSc², Marc Hammer, MSc³, James O'Kelly, PhD⁴, Florian Scholz, BS³, Greg Kricorian, MD¹, Walter Reinisch, MD, PhD⁵
¹Amgen Inc., Thousand Oaks, CA; ²IQVIA, Frankfurt, Hessen, Germany; ³IQVIA Germany, Munchen, Bayern, Germany; ⁴Center for Observational Research, Amgen Inc., Uxbridge, England, United Kingdom; ⁵Medical University of Vienna, Vienna, Wien, Austria

Introduction: ABP 501 (AMGEVITA®) is the first adalimumab biosimilar approved by the FDA and the EMA for treating certain immune-mediated inflammatory diseases, including inflammatory bowel disease (IBD). Real-world evidence from European countries on utilization patterns of ABP 501 can provide valuable data ahead of US market entry.

Methods: This retrospective cohort analysis using the IQVIA German pharmacy claims database included patients (≥18 years) with documented evidence of IBD diagnosis (Crohn’s disease or ulcerative colitis) who received ABP 501 between October 2018 and March 2020 and had ≥365 days of continuous observation both pre- and post-initiation of ABP 501. Descriptive statistics were used to report treatment history at baseline (12 months prior to ABP 501 initiation) and concomitant medication use while receiving ABP 501. Persistence was evaluated using Kaplan-Meier analysis with a permissible treatment gap of up to 120 days.

Results: For the 3,362 patients included in the analysis, mean age was 41 years, 49% were women, most were treated primarily in an office-based clinical setting (85%) and by gastroenterologists (73%) (Table). In total, 54% (n=1,828) had no prior exposure to adalimumab (ADA) reference product (RP) or other ADA biosimilars (ADA-naïve patients) and 46% (n=1,534) were previously treated with ADA RP or biosimilars (Switchers) during baseline. Prior use of glucocorticoids (54% vs. 27%), immunosuppressive drugs (25% vs. 15%), and other biologics (including non-ADA TNF inhibitors [TNFi]; 15% vs. 4%) at baseline was more common for ADA-naïve patients than Switchers. Median persistence of ABP 501 was 12.1 (95% CI: 11.3 – 13.0) months, with numerically higher persistence being observed in Switchers (14.1 months, 95% CI: 12.7 – 15.3) than ADA-naïve patients (10.9 months, 95% CI: 9.8 – 11.6). Approximately one-fifth of all patients switched from ABP 501 to other advanced therapies within 12 months of ABP 501 initiation, most frequently to other non-TNFi biological therapies (9.3% of all patients) followed by switching to the RP (6.6% of all patients).

Discussion: Our findings suggested an overall low switch rate to RP among patients receiving ABP 501 for treating IBD. Higher treatment persistence was observed in Switchers than ADA-naïve patients. However, differences in prior medication use at baseline need to be taken into consideration when interpreting data across groups.

	All patients	Adalimumab-naïve patients^a	Switchers^b
Patient count	3,362	1,828	1,534^c
Age in years, mean (SD)	40.9 (14.4)	40.1 (14.2)	41.9 (14.7)
Sex, n (%)
Female	1,637 (48.7%)	887 (48.5%)	750 (48.9%)
Male	1,280 (38.1%)	716 (39.2%)	564 (36.8%)
Unknown	445 (13.2%)	225 (12.3%)	220 (14.3%)
Treating specialty, n (%)
Dermatologists	2 (0.1%)	1 (0.1%)	1 (0.1%)
Gastroenterologist	2,468 (73.4%)	1,346 (73.6%)	1,122 (73.1%)
Rheumatologist	98 (2.9%)	46 (2.5%)	52 (3.4%)
Unknown	794 (23.6%)	435 (23.8%)	359 (23.4%)
Treatment setting, n (%)
Hospital-based	506 (15.1%)	284 (15.5%)	222 (14.5%)
Office-based	2,856 (85.0%)	1,544 (84.5%)	1,312 (85.5%)
Prior treatment at baseline^d, n (%)
Non-steroidal anti-inflammatory drugs (NSAIDs)	566 (16.8%)	323 (17.7%)	243 (15.8%)
Glucocorticoids	1,410 (41.9%)	994 (54.4%)	416 (27.1%)
Immunosuppressive drugs	678 (20.2%)	453 (24.8%)	225 (14.7%)
Tumor necrosis factor inhibitor (TNFi; excluding adalimumab)	225 (6.7%)	184 (10.1%)	41 (2.7%)
Other biologics (excluding TNFi)	104 (3.1%)	88 (4.8%)	16 (1%)
Janus kinase inhibitor (JAKi)	12 (0.4%)	12 (0.7%)	0 (0.0%)
Concomitant treatment, n (%)
NSAIDs	443 (13.2%)	216 (11.8%)	227 (14.8%)
Glucocorticoids	812 (24.2%)	522 (28.6%)	290 (18.9%)
Immunosuppressive drugs	327 (9.7%)	187 (10.2%)	140 (9.1%)

^aAdalimumab-naïve patients were those with no previous use of adalimumab reference product or other adalimumab biosimilars within 12 months prior to ABP 501 initiation.

^bSwitchers were patients who were previously treated with adalimumab reference product or other adalimumab biosimilars within 12 months prior to ABP 501 initiation. Adalimumab-naïve patients and Switchers are mutually exclusive categories.

^cn=1,297 were switched to ABP 501 from adalimumab reference product and n=237 were switched from other adalimumab biosimilars.

^dCategories are not mutually exclusive. Patients were possibly treated with more than 1 categories of drugs during baseline.

Disclosures:

Ran Jin: Amgen – Employee, Stock Options.

Silvia Kruppert indicated no relevant financial relationships.

Marc Hammer: AbbVie – Employee. IQVIA – Employee.

James O'Kelly: Amgen – Employee, Stock Options.

Florian Scholz indicated no relevant financial relationships.

Greg Kricorian: Amgen – Employee, Stock Options.

Walter Reinisch: 4SC – Advisory Committee/Board Member, Consultant. Abbott Laboratories – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. AbbVie – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Aesca – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Algernon – Consultant. AM Pharma – Advisory Committee/Board Member, Consultant. Amgen – Advisory Committee/Board Member, Consultant. AMT – Consultant. AOP Orphan – Consultant. Aptalis – Speakers Bureau. Arena Pharmaceuticals – Consultant. Astellas – Advisory Committee/Board Member, Consultant, Speakers Bureau. AstraZeneca – Advisory Committee/Board Member, Consultant. Avaxia – Advisory Committee/Board Member, Consultant. Bioclinica – Consultant. Biogen IDEC – Advisory Committee/Board Member, Consultant. Boehringer Ingelheim – Advisory Committee/Board Member, Consultant. Bristol Myers Squibb – Advisory Committee/Board Member, Consultant. Celgene – Advisory Committee/Board Member, Consultant. Cellerix – Advisory Committee/Board Member, Consultant. Celltrion – Advisory Committee/Board Member, Consultant, Speakers Bureau. Centocor – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. ChemoCentryx – Advisory Committee/Board Member, Consultant. Covance – Consultant. Danone Austria – Advisory Committee/Board Member, Consultant, Speakers Bureau. DSM – Advisory Committee/Board Member, Consultant. Elan – Advisory Committee/Board Member, Consultant, Speakers Bureau. Eli Lilly – Consultant. Ernest & Young – Consultant. Falk Pharma GmbH – Consultant, Grant/Research Support, Speakers Bureau. Ferring – Advisory Committee/Board Member, Consultant, Speakers Bureau. Galapagos – Advisory Committee/Board Member, Consultant. Gatehouse Bio – Consultant. Genentech – Advisory Committee/Board Member, Consultant. Gilead – Consultant. Grünenthal – Advisory Committee/Board Member, Consultant. ICON – Consultant. Immundiagnostik – Grant/Research Support, Speaker. Index Pharma – Consultant. Inova – Advisory Committee/Board Member, Consultant. Intrinsic Imaging – Consultant. Janssen – Advisory Committee/Board Member, Consultant, Grant/Research Support. Johnson & Johnson – Advisory Committee/Board Member, Consultant. Kyowa Hakko Kirin Pharma – Advisory Committee/Board Member, Consultant. Lipid Therapeutics – Advisory Committee/Board Member, Consultant. LivaNova – Consultant. Mallinckrodt – Consultant. Medahead – Consultant. MedImmune – Advisory Committee/Board Member, Consultant. Millenium – Advisory Committee/Board Member, Consultant. Mitsubishi Tanabe Pharma Corporation – Advisory Committee/Board Member, Consultant, Speakers Bureau. MSD – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Nash Pharmaceuticals – Consultant. Nestle – Advisory Committee/Board Member, Consultant. Nippon Kayaku – Consultant. Novartis – Advisory Committee/Board Member, Consultant. Ocera – Advisory Committee/Board Member, Consultant. OMass – Consultant. Otsuka – Advisory Committee/Board Member, Consultant, Speakers Bureau. Parexel – Consultant. PDL – Advisory Committee/Board Member, Consultant, Speakers Bureau. Periconsulting – Consultant. Pfizer – Advisory Committee/Board Member, Consultant. Pharmacosmos – Advisory Committee/Board Member, Consultant, Speakers Bureau. Philip Morris Institute – Consultant. PLS Education – Speakers Bureau. Procter & Gamble – Advisory Committee/Board Member, Consultant. Prometheus – Advisory Committee/Board Member, Consultant. Protagonist – Consultant. Provention – Consultant. Quell Therapeutics – Consultant. Robarts Clinical Trial – Consultant. Roland Berger GmbH – Consultant. Sandoz – Advisory Committee/Board Member, Consultant, Grant/Research Support. Schering-Plough – Advisory Committee/Board Member, Consultant, Speakers Bureau. Second Genome – Advisory Committee/Board Member, Consultant. Seres Therapeutics – Consultant. Setpoint Medical – Advisory Committee/Board Member, Consultant. Shire – Speakers Bureau. Sigmoid – Consultant. Sublimity – Consultant. Takeda – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Therakos – Advisory Committee/Board Member, Consultant, Speakers Bureau. Theravance – Consultant. TiGenix – Advisory Committee/Board Member, Consultant. UCB – Advisory Committee/Board Member, Consultant. Vifor – Consultant, Speakers Bureau. Yakult – Speakers Bureau. Zealand – Advisory Committee/Board Member, Consultant. Zyngenia – Advisory Committee/Board Member, Consultant.

Ran Jin, MD, PhD¹, Silvia Kruppert, MSc², Marc Hammer, MSc³, James O'Kelly, PhD⁴, Florian Scholz, BS³, Greg Kricorian, MD¹, Walter Reinisch, MD, PhD⁵. E0400 - Treatment Patterns of an Adalimumab Biosimilar (ABP 501) Among Patients With Inflammatory Bowel Disease: An Observational Study Using German Pharmacy Claims Database, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.